Support and Outreach to Increase Screening for Lung Cancer in Patients With a History of Smoking

Sponsor

Thomas Jefferson University (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05679349

Collaborator

(none)

822

Enrollment

Location

Arms

53.9

Anticipated Duration (Months)

15.2

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This clinical trial tests how well providing education improves screening for lung cancer in patients with a history of smoking. Screenings may help doctors find lung cancer sooner when it may be easier to treat. Education and counseling may be an effective method to help providers and patients learn about lung cancer screening. Providing education and decision counseling to providers and patients may increase lung cancer screening.

Condition or Disease	Intervention/Treatment	Phase
Lung Carcinoma Tobacco-Related Carcinoma	Other: Survey Administration Other: Educational Activity Other: Survey Administration Other: Electronic Health Record Review Other: Educational Activity Other: Counseling Other: Survey Administration Other: Electronic Health Record Review	N/A

Detailed Description

PRIMARY OBJECTIVES:

Assess intervention impact on lung cancer screening (LCS). II. Assess intervention impact on shared decision making (SDM).

SECONDARY OBJECTIVES:

Identify mediators and moderators of LCS. II. Assess intervention implementation barriers and facilitators.

EXPLORATORY OBJECTIVES:

I. Assess intervention impact on:

Ia. LCS referral; Ib. Tobacco treatment services referral; Ic. Repeat annual LCS among participants with a normal initial screening result; Id. Follow-up diagnostic evaluation for participants with an abnormal screening result.

OUTLINE: Providers are randomized to 1 of 2 groups. Patients are randomized to 1 of 2 groups.

PROVIDERS:

GROUP A: PROVIDER SUPPORT GROUP: Participants complete survey on study. Participants undergo online educational activity on study. Participants undergo distance learning on study.

GROUP B: PROVIDER CONTROL GROUP: Participants complete survey at baseline and end of study survey.

PATIENTS:

GROUP A: Patients undergo electronic health records (EHR) review on study. Patients undergo educational activity on study. Patients also undergo SDM counseling once on study.

GROUP B: Patients undergo EHR review on study and complete telephone survey throughout the trial.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

822 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Screening

Official Title:

Provider Support and Patient Outreach in Lung Cancer Screening

Anticipated Study Start Date :

Jan 1, 2023

Anticipated Primary Completion Date :

Jan 1, 2027

Anticipated Study Completion Date :

Jul 1, 2027

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Group A (Providers): (survey, online educational activity) Participants complete survey on study. Participants undergo online educational activity on study. Participants undergo distance learning on study.	Other: Survey Administration Complete survey Other: Educational Activity Undergo online shared decision making training and distance learning
Active Comparator: Group B (Providers): (survey) Participants complete survey at baseline and end of study survey.	Other: Survey Administration Complete survey
Experimental: Group A (Patients): (EHR, educational activity, counseling)) Patients undergo EHR review on study. Patients undergo educational activity on study. Patients also undergo SDM counseling once on study.	Other: Electronic Health Record Review Undergo electronic health record review Other: Educational Activity Undergo online shared decision making training and distance learning Other: Counseling Undergo shared decision making counseling Other Names: Counseling Intervention
Active Comparator: Group B (Patients): (survey) Patients undergo EHR review on study and complete telephone survey throughout the trial.	Other: Survey Administration Complete survey Other: Electronic Health Record Review Undergo electronic health record review

Outcome Measures

Primary Outcome Measures

Completion of initial lung cancer screening (LCS) [Within 4 months of randomization]
LCS will be assessed through an endpoint electronic medical records (EMR) search, supplemented with a question on the participant endpoint survey to capture any LCS performed outside the health system and/or not captured in the EMR.

Secondary Outcome Measures

Referral for LCS [Up to 5 years]
Referrals for lung cancer screenings will be found by reviewing electronic medical records.
Tobacco cessation services [Up to 5 years]
Referrals for tobacco treatment services will be found by reviewing medical records.
Repeat annual lung cancer screenings within 11-16 months of original screening [within 11-16 months of original screening]
Number of repeat screenings will be found by reviewing electronic medical records.
Diagnostic follow up after initial lung cancer screening [Up to 4 months of screening]
Number of patients that had follow up within 4 months of initial lung cancer screening will be found by reviewing electronic medical records.

Eligibility Criteria

Criteria

Ages Eligible for Study:

50 Years to 77 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

PRACTICE LEVEL:
Primary care practice (family medicine, geriatrics, internal medicine) in one of the 4 participating health systems
Practice using the main electronic medical record (EMR) of each system, in order to run appropriate patient recruitment reports
Practice with at least 50% of practice providers (physicians and advanced care providers) consenting to participate
PATIENT LEVEL:
Have an office or telemedicine established patient visit scheduled with a primary care provider in one of the participating practices within next 14 to 25 days
50 to 77 years of age
Have at least a 20-pack-year smoking history (based on self-report at baseline eligibility assessment)
Currently smoke or have quit smoking within the past 15 years (based on self-report at baseline eligibility assessment)
Able to communicate in English or Spanish (determined at baseline eligibility assessment)

Exclusion Criteria:

PATIENT OUTREACH:
Any lung computed tomography (CT) or low-dose computed tomography (LDCT) scan in the past 11 months, current procedural terminology (CPT) Codes are as follows
G0297 - LDCT screening
71250 - CT w/o contrast
71260 - CT w/ contrast
71270 - CT with and w/o contrast
71275 - CT angiography chest
78815 - Positron emission tomography computed tomography (PET CT) skull base to mid-thigh
78816 - PET CT whole body
Prior history of lung cancer (The patient's problem list includes a problem with an international classification of diseases (ICD10) code of "Z85.118" or one beginning with "C34.", or by self-report at baseline eligibility assessment)
Recent hospitalization (Admission date within the last 60 days listed in electronic health record (EHR), or by self-report at baseline eligibility assessment)
Dementia (diagnosis codes F03.90 or F03.91) in EHR

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Sidney Kimmel Cancer Center at Thomas Jefferson University	Philadelphia	Pennsylvania	United States	19107

Sponsors and Collaborators

Thomas Jefferson University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Thomas Jefferson University

ClinicalTrials.gov Identifier:

NCT05679349

Other Study ID Numbers:

22F.808

First Posted:

Jan 11, 2023

Last Update Posted:

Jan 18, 2023

Last Verified:

Jan 1, 2023

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Carcinoma

Study Results

No Results Posted as of Jan 18, 2023